Emergent BioSolutions Initiates Pivotal Clinical Trial Evaluating a Three-Dose BioThrax Regimen for Post-Exposure Prophylaxis

Emergent BioSolutions Inc. (NYSE: EBS) today announced the initiation of a pivotal immunogenicity and safety study to evaluate a three-dose vaccination schedule of BioThrax® (Anthrax Vaccine Adsorbed) for administration to individuals exposed to anthrax. Through this pivotal, licensure-enabling clinical study, the company seeks to obtain a post-exposure prophylaxis indication for BioThrax.

Approval of the PEP indication would expand use of BioThrax beyond its current pre-exposure prophylaxis indication to add an indication in which the vaccine would be used in combination with antibiotics in people who have potentially been exposed to anthrax spores. Immune protection in this setting is important because of the potential for residual anthrax spores to germinate and cause disease after the currently recommended 60-day course of antibiotic treatment has stopped. BioThrax is the only vaccine licensed by the U.S. Food and Drug Administration for the prevention of anthrax disease.

“Emergent is pleased to be working with BARDA to broaden the clinical utility of BioThrax and to further enhance its features in support of the U.S. government's biodefense needs,” said Daniel J. Abdun-Nabi, president and chief operating officer of Emergent BioSolutions.